|Trade Name||SELUTE AND SELUTE PICOTIP|
|Classification Name||permanent pacemaker electrode|
|Generic Name||alternate endocardial lead stabilizer component|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to extend the shelf life of the drug plug component of the leads from one year to three years. The shelf life of the finished leads remains two years.